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NCT01518478 · ClinicalTrials.gov registry record · Early Phase 1

Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot

A Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Early Phase 1
Development phase
40
Enrollment target

NCT01518478 is a Early Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants.

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The verdict

NCT01518478, a Early Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Early Phase 1
Development phase
40 participants
Enrollment target

Study Summary

A new flu vaccine which is injected into the skin instead of into the muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis (AD). This new vaccine has been shown to work as well as the vaccine which is injected into muscle when tested in people without atopic dermatitis. The primary endpoint of the study is to estimate the variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and participants with atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.

Interventions

  • DRUG Fluzone® Intradermal (Sanofi Pasteur Inc.)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2011-11
Est. Completion 2012-03
Phase Early Phase 1

What the Registry Record Tells You About NCT01518478

The ClinicalTrials.gov registry entry for NCT01518478 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Fluzone® Intradermal (Sanofi Pasteur Inc.) is the first listed.

NCT01518478 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01518478 about?

NCT01518478 is a clinical study titled "Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot". A new flu vaccine which is injected into the skin instead of into the muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis (AD). This new vaccine has been shown to work as well as the vaccine which i...

What is the current status of trial NCT01518478?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2011-11. Estimated completion is 2012-03.

What interventions are being tested in trial NCT01518478?

The interventions under investigation include: Fluzone® Intradermal (Sanofi Pasteur Inc.) (DRUG).

Who is sponsoring clinical trial NCT01518478?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.